Reported Jun 28, 2023 · Ongoing
ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
ICD-VR DVAB1D1 VISIA AF US IS1/DF1Model Number DVAB1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720619
- Lot Serial Numbers
425 of 425 codes
BWN203363HBWN203588HBWN203428HBWN203504HBWN203530HBWN203214HBWN203258HBWN203259HBWN203304HBWN203477HBWN203665HBWN203423HBWN203403HBWN203327HBWN203518HBWN203790HBWN203174HBWN203624HBWN203750HBWN203763HBWN203786HBWN203745HBWN203526HBWN203813HBWN203168HBWN203236HBWN203374HBWN203463HBWN203640HBWN203213HBWN203431HBWN203492HBWN203585HBWN203436HBWN203524HBWN203528HBWN203809HBWN203432HBWN203231HBWN203199HBWN203163HBWN203193HBWN203306HBWN203310HBWN203352HBWN203373HBWN203433HBWN203575HBWN203611HBWN203616HBWN203689HBWN203732HBWN203739HBWN203749HBWN203796HBWN203799HBWN203803HBWN203181HBWN203642HBWN203202H
- Amount recalled
- 425 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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